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Details for Patent: 6,121,295

Details for Patent: 6,121,295

Title:

Pharmaceutical composition

Abstract:

Pharmaceutical composition which comprises an insulin sensitivity enhancer in combination with other antidiabetics differing from the enhancer in the mechanism of action, which shows a potent depressive effect on diabetic hyperglycemia and is useful for prophylaxis and treatment of diabetes.

1. A method for treating diabetic complications in a mammal in need thereof, which comprises administering to such mammal a therapeutically effective amount of an insulin sensitivity enhancer in combination with a statin compound.

2. The method according to claim 1, wherein the insulin sensitivity enhancer is a compound represented by the formula: ##STR8## wherein R represents an optionally substituted hydrocarbon or heterocyclic group; Y represents a group represented by --CO--, --CH(OH)-- or --NR.sup.3 -- wherein R.sup.3 represents an optionally substituted alkyl group; m is 0 or 1; n is 0, 1 or 2; X represents CH or N; A represents a bond or a C.sub.1-7 divalent aliphatic hydrocarbon group; Q represents oxygen atom or sulfur atom; R.sup.1 represents hydrogen atom or an alkyl group; ring E may optionally have further 1 to 4 substituents, and the substituents may optionally be combined with R.sup.1 to form a ring; L and M respectively represent hydrogen atom, or L and M may optionally be

combined with each other to form a bond; or a pharmacologically acceptable salt thereof.

3. The method according to claim 2, wherein R is an optionally substituted heterocyclic group.

8. The method according to claim 2, wherein L and M are hydrogen atom.

9. The method according to claim 31, wherein R is pyridyl, oxazolyl or thiazolyl group optionally having 1 to 3 substituents selected from C.sub.1-3 alkyl, furyl, thienyl, phenyl and naphthyl; m is 0; n is 0 or 1; X is CH; A is a bond or --(CH.sub.2).sub.2 --; R.sup.1 is hydrogen atom; the partial formula: ##STR10## and R.sup.2 is hydrogen atom or C.sub.1-4 alkoxy group; and L and M are both hydrogen atom.

10. The method according to claim 2, wherein the compound represented by the formula (I) is pioglitazone.

11. The method according to claim 1, wherein the insulin sensitivity enhancer is pioglitazone or its hydrochloride.

12. The method according to claim 1, wherein the insulin sensitivity enhancer is troglitazone.

13. The method according to claim 1, wherein the statin compound is selected from the group consisting of pravastatin and its sodium salt, simvastatin, lovastatin, atorvastatin and fluvastatin.

14. The method according to claim 1, wherein the insulin sensitivity enhancer and statin compound are mixed together to form an admixture and the admixture is administered to the mammal.

15. The method according to claim 1, wherein the insulin sensitivity enhancer and statin compound are not mixed together but are administered independently to the mammal.

16. The method according to claim 1, wherein the insulin sensitivity enhancer is 5-[[4-[2-(methyl-2-pyridylamino) ethoxyl]phenyl]-methyl]-2,4-thiazolidinedione or its pharmacologically acceptable salts.

17. The method according to claim 1 wherein the statin compound is pravastatin or its sodium salt.

18. The method according to claim 1, wherein the statin compound is slimvastatin.

19. The method according to claim 1, wherein the statin compound is lovastatin.

20. The method according to claim 1, wherein the statin compound is atorvastatin.

21. The method according to claim 1, wherein the statin compound is fluvastatin.

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